A Phase IV, Randomized, Double Blind, Single Centre, Placebo Controlled Study to Assess the Safety and Efficacy of Methoxyflurane [Penthrox] for the Treatment of Incident Pain in Participants Undergoing a Bone Marrow Biopsy Procedure

Brief Summary

This study aims to provide further supportive evidence that Methoxyflurane, a potent analgesic, administered using the Penthrox Inhaler is safe and efficacious in adult participants, specifically those who experience incident pain associated with a planned bone marrow biopsy.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Estimated Enrollment ICMJE

110

Completion Date

November 2009

Primary Completion Date

Not Provided

Eligibility Criteria ICMJE

Inclusion Criteria:

Adult participants (18 years of age or older)

Able to give written informed consent

Anticipated episode(s) of incident pain related to planned BMB lasting no more than 30 minutes on average

Anticipated life expectancy of at least 1 month

Pre-Exclusion Criteria:

Subjects with a clinical condition that may, in the opinion of the investigator, impact on the subject's ability to participate in the study, or on the study results

Participants who have had IV sedation/opioid on previous BMB and who wish to receive IV sedation/opioid on this occasion or who in the opinion of the BMB operator would be advised to receive IV sedation/opioid on this occasion

Concomitant use of other investigational agents

Concomitant use of nephrotoxic agents such as gentamicin

Uncontrolled INR (>4)

Personal or familial hypersensitivity to fluorinated anaesthetics

Personal or familial malignant hyperthermia

Respiratory rate of less than 10 per minute

Has previously received methoxyflurane

Known pre-existing renal or hepatic impairment

Compromised Renal Function (creatinine ≥ 1.5 x ULNR)

Compromised Liver Function (bilirubin ≥ 2.5 x ULNR)

Exclusion Criteria:

Premedication with anxiolytic (e.g. midazolam, diazepam)

Dosed with breakthrough dose of analgesic that may contribute to control of pain during the planned procedure

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects